Devices and methods for suture placement

ABSTRACT

A suturing device includes an elongate body, a needle holder, and an actuator. The needle holder extends away from a distal end portion or is provided as part of the distal end portion of the elongate body. The needle holder defines a needle passage configured to hold an associated needle. The actuator is operable between a first operating position and a second operating position, and is configured such that movement from the first operating position toward the second operating position moves the associated needle in an advance direction. The actuator includes a manually operated member and a biasing mechanism biasing the actuator toward the second operating position. The manually operated member is operatively connected with the biasing mechanism so as to preclude the biasing mechanism from moving the actuator toward the second operating position until after the manually operated member has been moved from a non-actuated position toward an actuated position.

BACKGROUND

The present disclosure relates generally to surgery and the placement ofsutures, and more particularly, to devices and methods for the suturerepair of tissue.

Surgical closure techniques using sutures is one approach to tissuerepair. In some instances, however, these techniques can be difficult toexecute due to anatomic constraints, obstruction of visualization byblood or other bodily fluids, and the proximity to nerve rootlets. Insome instances, these challenges can be further complicated when usingminimally invasive techniques such as, for example, a tubular retractor.Traditional tools and devices can be limited and, in some instances,lack maneuverability to avoid obstructions and/or to enable adequatepassage of the needle and suture through the tissue.

SUMMARY

In view of the foregoing a suturing device includes an elongate body, aneedle holder, and an actuator. The elongate body includes a proximalend portion and a distal end portion. The needle holder extends awayfrom the distal end portion or is provided as part of the distal endportion. The needle holder includes a distal end section having adistal-most tip. The needle holder defines a needle passage configuredto hold an associated needle and a distal opening. The actuatorinteracts with the elongate body and is operable between a firstoperating position and a second operating position. The actuator isconfigured such that movement of the actuator from the first operatingposition toward the second operating position moves the associatedneedle in an advance direction. The actuator includes a manuallyoperated member and a biasing mechanism biasing the actuator toward thesecond operating position. The manually operated member is operativelyconnected with the biasing mechanism so as to preclude the biasingmechanism from moving the actuator toward the second operating positionuntil after the manually operated member has been moved from anon-actuated position toward an actuated position.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view a suturing device.

FIG. 2 is a perspective view the suturing device of FIG. 1 with a handleremoved to show components of an actuator.

FIG. 3 is a cross-sectional view of a lower portion of the suturingdevice of FIG. 1.

FIG. 4 is a cross-sectional view of an upper portion of the suturingdevice of FIG. 1 with a plunger in an extended position.

FIG. 5 is a side view of the lower portion of the suturing device ofFIG. 1.

FIG. 6 is a front view of the lower portion of the suturing device ofFIG. 1.

FIG. 7 is a cross-sectional view of the upper portion of the suturingdevice of FIG. 1 with a plunger in a depressed position.

FIG. 8 is a perspective view of a manually operated member for thesuturing device of FIG. 1.

FIG. 9 is a perspective view of an alternative suturing device.

FIG. 10 is a perspective view an upper portion of the suturing device ofFIG. 9 with a handle removed to show components of an actuator.

FIG. 11 is a cross-sectional view of an upper portion of the suturingdevice of FIG. 9.

DETAILED DESCRIPTION

FIG. 1 depicts an example of a suturing device 10 that is useful tosuture tears in tissue and that can be used in many different types ofsurgical procedures. With reference to FIG. 2, the suturing device 10generally includes an actuator 12, an elongate body 14, and a needleholder 16. The suturing device 10 is particularly useful during aminimally invasive surgical procedure that is performed through atubular retractor or other small surgical portal to accurately locate aneedle 20 and a suture 22, which are shown in FIG. 3, to facilitatepassing the needle 20 through target tissue to be sutured.

The needle 20 in the illustrated embodiment is a curved needle having afirst end 30, which is pointed, and a second end 32, which is oppositeto the first end 30. The needle 20 can be similar to commerciallyavailable curved needles made from known materials. The needle 20 couldalso be formed from a malleable, or flexible, material such that theneedle 20 could follow a curve when positioned within the needle holder16, which is curved, and then later straighten after exiting the needleholder 16. Both the needle holder 16 and the needle 20 can take otherconfigurations, such as straight.

Actuation of the actuator 12 moves the needle 20 in an advance direction36 with respect to the needle holder 16. The needle 20 moves from aretracted position, which is shown in FIG. 3, to a released condition inwhich the needle 20 is released from the needle holder 16. When in thereleased condition, the surgeon can grasp the needle 20, for examplewith forceps, and pull the needle 20 and the suture 22. The suture 22connects with the needle 20 and extends from the second end 32 of theneedle 20. The suture 22 can be swaged to the second end 32 of theneedle 20. The suture 22 can also connect with the needle 20 in otherconventional manners. The suture 22 can be acquired from known suturemanufacturers.

The actuator 12 is operable between a first operating position and asecond operating position. Movement of the actuator 12 from the firstoperating position toward the second operating position moves the needle20 in the advance direction 36 with respect to the needle holder 16 thusmoving the needle 20 toward the released condition in which the needle20 is released from the needle holder 16. In the illustrated embodiment,the actuator 12 includes a flexible section, which in the illustratedembodiment is made up of a wire 40, which can be made from nitinol. Theflexible section is configured to bend within the needle holder 16 whenthe actuator 12 is moved from the first operating position toward thesecond operating position. The other components of the actuator 12 willbe described in more detail below.

The elongate body 14 connects with a handle 50 in the illustratedembodiment. The elongate body 14 in the illustrated embodiment is in theform of a cannula. The elongate body 14 has an outer surface 60, whichis smooth, and defines a track 62 that receives a portion of theactuator 12, more particularly the wire 40 in the illustratedembodiment. As described above, the elongate body 14 is a cannula andthe track 62 is a lumen that receives the wire 40 of the actuator 12.The track 62 need not encircle the wire 40, but could be U-shaped. Inthe depicted embodiments, the elongate body 14 is circular in a crosssection taken normal to the longest dimension of the elongate body 14,however, the elongate body 14 could take alternative configurations,such as polygonal or U-shaped.

The elongate body 14 has a bayonet configuration in the illustratedembodiment; however, the elongate body 14 could take alternativeconfigurations, such as straight along a longitudinal axis. The elongatebody 14 includes the proximal end portion 70 and a distal end portion 72connected by an intermediate portion 74. The proximal end portion 70connects with the handle 50 in a manner that will be described in moredetail below. In the illustrated embodiment, the needle holder 16 isreceived in and connected with the elongate body 14 and extends awayfrom the distal end portion 72. Alternatively, the needle holder 16 canbe provided as part of the distal end portion 72 of the elongate body14. The elongate body 14 is made from a rigid metal material; however,if desired at least a portion of the elongate body 14 may be made from amalleable or flexible material to allow the surgeon to bend at least aportion of the elongate body 14 into a desirable configuration forinsertion into an animal body during a surgical procedure. In theillustrated embodiment, an outer diameter of the elongate body 14 isconstant between the proximal end portion 70 and the distal end portion72. The outer diameter can be less than 3.5 mm, which provides a veryslim device to enhance the line of sight for a surgeon during thesurgical procedure.

The intermediate portion 74 is positioned between the proximal endportion 70 and the distal end portion 72. The proximal end portion 70extends along a proximal end portion longitudinal axis 76. The distalend portion 72 extends along a distal end portion longitudinal axis 78,which is offset from the proximal end portion longitudinal axis 76 in aforward direction. In the illustrated embodiment, the distal end portionlongitudinal axis 78 is offset from the proximal end portionlongitudinal axis 76 about 25 mm. The proximal end portion 70transitions to the intermediate portion 74 through a proximal bend 82and the intermediate portion 74 transitions to the distal end portion 72through a distal bend 84. In the illustrated embodiment, the proximalbend 82 and the distal bend 84 are both angled internally 135 degrees.

With reference to FIG. 4, the proximal end portion 70 of the elongatebody 14 is received in an elongate body passage 86 provided in thehandle 50. The elongate body passage 86 has a configuration in crosssection normal to the proximal end portion longitudinal axis 76 nearlyidentical (and only slightly larger, if desired) to the proximal endportion 70 of the elongate body 14. The elongate body 14 and the needleholder 16 are rotatable with respect to the handle 50 about a rotationalaxis, which in the illustrated embodiment is coaxial with the proximalend portion longitudinal axis 76; however, rotation of the elongate body14 and the needle holder 16 with respect to the handle 50 requires agreater amount of force to be applied on the elongate body 14 or needleholder 16 than the force that is typically applied to the elongate body14 or the needle holder 16 while a surgeon is using the suturing device10 during a suturing procedure.

In the illustrated embodiment, an elongate body retainer 90 connectswith the handle 50 and is configured to allow for rotation of theelongate body 14 with respect to the handle 50 about the rotational axis76. The elongate body retainer 90 also connects with the handle 50 so asto preclude translational movement of the elongate body 14 with respectto the handle 50 along or parallel to the rotational axis 76. In theillustrated embodiment, the elongate body retainer 90 is barrel shapedelement having a diameter that is greater than the diameter of theproximal end portion 70. The elongate body retainer 90 is fixed to theelongate body 14 at the proximal end portion 70 so as to rotate alongwith the elongate body 14. The elongate body retainer 90 is received inthe handle 50. The elongate body retainer 90 has an outer surface 92that is circular in a cross section taken normal to the rotational axis76 and is received in an elongate body retainer cavity 94 provided inthe handle 50. The elongate body retainer cavity 94 has an inner surface96 that is also circular in a cross section taken normal to therotational axis 76.

The outer surface 92 of the elongate body retainer 90 contacts the innersurface 96 of the elongate body retainer cavity 94 so that the elongatebody 14 and the needle holder 16 move and rotate along with the handle50 as the handle 50 is moved and rotated. The interface between theouter surface 92 of the elongate body retainer 90 and the inner surface96 of the elongate body retainer cavity 94 allows for rotation of theelongate body retainer 90, and thus the elongate body 14 and the needleholder 16, with respect to the handle 50 when an operator grasps thehandle 50 to preclude its rotation while rotating the elongate body 14or the needle holder 16. The elongate body passage 86 transitions to theelongate body retainer cavity 94 at an upper shoulder 98, and theelongate body retainer cavity 94 transitions back to the elongate bodypassage 86, which is smaller in diameter, at a lower shoulder 102. Theupper shoulder 98 and the lower shoulder 102 preclude translationalmovement of the elongate body retainer 90, and thus the elongate body 14and the needle holder 16, with respect to the handle 50.

The needle holder 16 extends away from the distal end portion 72 or isprovided as part of the distal end portion 72 of the elongate body 14.With reference to FIG. 3, the needle holder 16 is a hollow tubularmember. In the illustrated embodiment, a portion of the needle holder 16that is aligned with the distal end portion longitudinal axis 78 isreceived inside the elongate body 14; however, the needle holder 16could be formed as part of the elongate body, e.g., both the elongatebody 14 and the needle holder 16 could be made from one tubular stockmaterial. The needle holder 16 depicted in the illustrated embodiment isa curved needle holder that generally follows a constant radius suchthat the suturing device 10 can have J-hook configuration at a distalend thereof. In the illustrated embodiment, the needle holder 16 is notintended to be removable from the elongate body 14; however, in analternative arrangement the needle holder 16 can selectively connectwith the elongate body 14 via a mechanical connection such as a frictionfit or a bayonet connection.

With reference to FIG. 3, the needle holder 16 includes a distal endsection 140 having a distal-most tip 142. The needle holder 16 defines aneedle passage 144 that is in communication with the track 120 and adistal opening 146. The distal opening 146 is offset from the distal endportion longitudinal axis 78 in a forward direction. In the embodimentdepicted in FIG. 3, at least a portion of the suture 22 extends alongthe needle passage 144 from the second end 32 of the needle 20 towardthe distal opening 146 between the needle 20 and an inner surface 152 ofthe needle holder 16 when the needle 20 is received in the needlepassage 144 and the actuator 12 is in the first operating position. Thedistal-most tip 142 is offset from the distal end portion longitudinalaxis 78 in a direction perpendicular from the distal end portionlongitudinal axis 78 a distance of less than 7 mm. Common tubularretractors used during minimally invasive spinal surgery procedures havediameters measuring between 14 mm to 22 mm. By spacing the distal-mosttip 142 offset from the distal end portion longitudinal axis 78 lessthan 7 mm, the surgeon can locate the elongate body 14 along the centralaxis of the tubular retractor and rotate the suturing device around thecentral axis without contacting the side of the tubular retractor.

As more clearly seen in FIG. 5, the needle holder 16 includes a notch160. With reference back to FIG. 3, as the needle 20 advances in theadvance direction 36, the first end 30 of the needle 20 can pass throughtarget tissue to be sutured. By providing the notch 160, the second end32 of the needle 20 need not travel past the distal-most tip 142 of theneedle holder 16 before being released from the needle holder 16. Such aconfiguration of the distal opening 146 also facilitates loading of theneedle 20 and the suture 22 into the needle passage 144, which occurs byinserting the second end 32 of the needle 20 into the distal opening 146and moving the needle 20 with respect to the needle holder 16 in adirection opposite to the advance direction 36. The configuration of thedistal opening 146 also mitigates the likelihood that the first end 30of the needle 20 may pass through the suture 22 when being passedthrough the target tissue 24.

The notch 160 is depicted on the side of the needle holder 16, however,the notch 160 can be located elsewhere. By providing the notch 160, thedistal opening 146 is non-circular. The distal-most tip 142 can also berounded (see FIG. 6), which allows for the surgeon to grab or “hook” thetarget tissue, which is to be sutured, on an internal side thereof andindent the target tissue with the distal-most tip 142 while not catchingthe target tissue with the first (pointed) end 30 of the needle 20.

The needle holder 16 also includes a proximal hole 162 that is locatedwhere the needle holder 16 begins to curve away from the distal endportion longitudinal axis 78. The proximal hole 162 is located on aninner side of the curve in the illustrated embodiment. The proximal hole162 extends into the needle passage 144 near where the second end 32 ofthe needle 20 resides when the needle 20 in the retracted position. Aneedle retainer can be provided to retain the needle 20 within theneedle passage 144 to inhibit unintended movement of the needle 20 withrespect to the needle holder 16. One example of such a needle retaineris a flexible sleeve 164 that surrounds the needle holder 16 andterminates at a lower end 166, which extends into the proximal hole 162to retain the second end 32 of the needle 20 against the inner surface152 of the needle holder 16 when the needle 20 is received in the needlepassage 144 in the retracted position. When the actuator 12 is movedfrom the first operating position to the second operating position, thewire 40 in the illustrated embodiment presses against the second end 32of the needle 20 overcoming the retaining force of the lower end 166 ofthe flexible sleeve 164 and moves the needle 20 in the advance direction36.

Other types or configurations of a needle retainer can be inserted intothe proximal hole 162, for example a resilient barbell shaped retainer168 (FIG. 5), to retain the needle 20 within the needle holder 16. Inthis alternative arrangement, when the resilient barbell shaped retainer168 is inserted into the proximal hole 162, the resilient barbell shapedretainer 168 presses the second end 32 of the needle 20 against theinner surface 152 of the needle holder 16 when the needle 20 is receivedin the needle passage 144 in the retracted position. When the actuator12 is moved from the first operating position to the second operatingposition, the wire 40 in the illustrated embodiment presses against thesecond end 32 of the needle 20 overcoming the retaining force of theresilient barbell shaped retainer 168 and moves the needle 20 in theadvance direction 36.

The handle 50 connects with the proximal end portion 70 of the elongatebody 14 and is fixed to the elongate body 14 such that movement of thehandle 50, e.g., rotational or translational movement, results in thesame movement of the elongate body 14, except for when a rotationalforce on the elongate body 14 overcomes the frictional force between theouter surface 92 of the elongate body retainer 90 and the inner surface96 of the elongate body retainer cavity 94. The elongate body passage 86extends from a distal handle end 196 toward a proximal handle end 198and is aligned with the proximal end portion longitudinal axis 76. Theelongate body passage 86 in the illustrated embodiment does not extendall the way from the distal handle end 196 to the proximal handle end198. In addition to the elongate body retainer cavity 94, the handle 50also includes an actuator cavity 200, which has a larger diameter thanthe elongate body passage 86 and the elongate body passage 86transitions into the actuator cavity 200 moving from the distal handleend 196 towards the proximal handle end 198. The actuator cavity 200transitions into a reduced diameter passage 202, which transitions intoa plunger head recess 204 at the proximal handle end 198. Barbs 206extend inwardly into the actuator cavity 200, and will be described inmore detail below. The handle 50 also includes a manually operatedmember hole 208 extending into the handle 50 from an outer side surface212 of the handle 50 into the actuator cavity 200. The handle 50 alsoincludes a manually operated member recess 210 aligned with the manuallyoperated member hole 208 in a direction perpendicular to the proximalend portion longitudinal axis 76.

The outer side surface 212 extends between the proximal handle end 198and the distal handle end 196. The outer side surface 212 follows asurface of revolution about the proximal end portion longitudinal axis76 along at least a majority of the handle 50 between the proximalhandle end 198 and the distal handle end 196. In the illustratedembodiment, the outer side surface 212 is generally cylindrical along atleast the majority of the handle 50 between the proximal handle end 198and the distal handle end 196. The maximum outer diameter of the handle50, which can also be referred to as a width measured perpendicular tothe proximal end portion longitudinal axis 76 since the handle 50 neednot be circular in a cross section normal to the proximal end portionlongitudinal axis 76, can be 10-20 mm. In the illustrated embodiment,the handle 50 has a width measured perpendicular to the proximal endportion longitudinal axis 76 of less than 12 mm. Common tubularretractors used during minimally invasive surgery procedures have innerdiameters measuring between 14 mm to 22 mm. The maximum width of thehandle 50 is not too large, which could impede the line of sight for thesurgeon during a surgical procedure, especially when the surgeon isworking through a tubular retractor or another small surgical portalother than a tubular retractor. The handle 50 measures about 12-13 cmfrom the proximal handle end 198 to the distal handle end 196, whichallows the surgeon to hold the suturing device similar to a pencil withthe portion of the handle 50 near the proximal handle end 198 resting inthe space between the forefinger and thumb of the surgeon.

With reference back to FIG. 1, the handle 50 also includes rotationgripping surfaces, which in the illustrated embodiment includes a firstrotation gripping surface 220 and a second rotation gripping surface(not visible in FIG. 1), each of which are nearer to planar as comparedto the majority of the outer side surface 212 of the handle 50, whichfollows the surface of revolution. The first rotation gripping surface220 is diametrically opposed from the second rotation gripping surface.The rotation gripping surfaces 220 can be gripped by an operator whilethe operator rotates the elongate body 14 with respect to the handle 50.Also, indicia, such as an arrow 222, can be provided on the handle 50 toindicate to the operator that the elongate body 14 can be rotated withrespect to the handle 50.

The actuator 12 interacts with the elongate body 14 and is operablebetween the first operating position and the second operating position.The actuator 12 is configured such that movement of the actuator 12 fromthe first operating position toward the second operating position movesthe needle 20 in the advance direction 36. With reference to FIG. 2, theactuator 12 includes a manually operated member 230, a biasing mechanism232, and a slider 234.

The manually operated member 230 is operatively connected with thebiasing mechanism 232 (through the slider 234 in the illustratedembodiment) so as to preclude the biasing mechanism 232 from moving theactuator 12 toward the second operating position until after themanually operated member 230 has been moved from a non-actuated position(shown in FIGS. 4 and 7) toward an actuated position where the manuallyoperated member 230 is depressed in the direction of arrow 236. Themanually operated member 230 includes an operator contact surface 238,which is concave in the illustrated embodiment. The handle 50 includesthe outer side surface 212, which is convex in the illustratedembodiment, and the operator contact surface 238 is concave to providean indication of the location of the operator contact surface 238 bytouch, as opposed to sight. Moreover, the operator contact surface 238extends outwardly from a widest diameter of the outer side surface 212of the handle 50 to also facilitate location of the operator contactsurface 238. The manually operated member 230 operates as a push buttonin the illustrated embodiment whereby an operator, such as a surgeon,depresses the manually operated member 230 in the direction of arrow 236moving the manually operated member 230 from the non-actuated positiontoward the actuated position in which a portion of the manually operatedmember 230 is received in the manually operated member recess 210provided in the handle 50. The manually operated member 230 alsoincludes a finger 242 which contacts an inner side surface 244 of theactuator cavity 200 to bias the manually operated member 230 toward thenon-actuated position. As more clearly seen in FIG. 8, the manuallyoperated member 230 includes a slider opening made up of a main portion246 and a smaller portion 248.

With reference back to FIG. 4, the biasing mechanism 232 in theillustrated embodiment is a spring. The spring 232 is a compressionspring that is configured to apply a force between 3N and 15N to theslider 234, which is operatively connected with the wire 40, whichpushes the needle 20 in the advance direction 36. More particularly, thespring 232 can be configured to apply a force between 9N and 11N to theslider 234. Limiting the force provided by the spring 232, or otherbiasing mechanism, reduces the likelihood of too great a force beingapplied to advance the needle 20 so that the needle 20 can pass throughthe target tissue while still being easily located by the surgeon duringa suturing procedure. Even though a compression spring is depicted inthe illustrated embodiment, other types of biasing mechanisms, forexample a pneumatic-type spring, could be utilized to advance theactuator 12 so as to deploy the needle 20.

The slider 234 includes a wire bore 250, which receives the wire 40 toconnect the wire 40 with the slider 234. The wire 40 is fixed to theslider 234 such that movement of the slider 234 results in movement ofthe wire 40. The slider 234 includes a biasing mechanism contact surface252, which is an upper end surface as depicted in FIG. 4. The slider 234also includes a manually operated member contact surface 254, which is alower surface of the slider 234 as illustrated in FIG. 4. The slider 234also includes a reduced cross-sectional portion 256 extending from arelatively larger cross-sectional portion 258. The relatively largercross-sectional portion has a diameter slightly smaller than the innerdiameter of the actuator cavity 200 to allow for translational movementof the slider 234 within the actuator cavity 200.

With reference back to FIG. 8, the main portion 246 of the slideropening is configured to receive the reduced cross-sectional portion 256of the slider 234 when the main portion 246 of the slider opening isaligned with the reduced cross-sectional portion 256. This occurs whenthe operator presses the operator contact surface 238 in the directionof arrow 236 thus moving the manually operated member 230 to the rightper the orientation shown in FIGS. 4 and 7. The main portion 246 of theslider opening, however, is smaller than the relatively largercross-sectional portion 258 of the slider 234. Accordingly, the traveldistance of the slider 234 is limited by the distance between manuallyoperated member contact surface 254 and a shoulder 262 where the reducedcross-sectional portion 256 transitions to the relatively largercross-sectional portion 258.

With reference back to FIG. 8, the smaller portion 248 of the slideropening is configured to allow for passage of the wire 40 to allow forthe connection of the wire 40 to the slider 234. When the manuallyoperated member is in the non-actuated position (shown in FIGS. 4 and7), the manually operated member 230 contacts the slider 234 to precludemovement of the slider 234 with respect to the manually operated member230. When an operator moves the manually operated member 230 in thedirection of arrow 236, the manually operated member 230 is moved in thedirection of arrow 236 which allows the main portion 246 of the slideropening to align with the reduced cross-sectional portion 256 of theslider, and the biasing mechanism 232 moves the slider 234 downwardly(per the orientation shown in FIGS. 4 and 7) such that the reducedcross-sectional portion 256 passes through the main portion 246 of theslider opening thus moving the wire 40 and thus moving the needle 20 inthe advance direction 36.

The suturing device 10 also includes a plunger 270 connected with thehandle 50 and movable with respect to the handle 50 between an extendedposition (FIGS. 1 and 4) and a depressed position (FIG. 7). Movement ofthe plunger 270 from the extended position to the depressed positioncompresses the spring 232. The plunger 270 includes a distal annularshoulder 272 that operates as a locating feature for the spring 232 andalso as a retaining feature to retain the plunger 270 in the depressedposition. With reference back to FIG. 7, when the plunger 270 is in thedepressed position the distal annular shoulder 272 engages the barb 206and the barb 206 counteracts the upward (per the orientation shown inFIG. 7) on the plunger 270 from the spring 232. When the spring 232 iscompressed by the plunger 270 with the plunger 270 in the depressedposition shown in FIG. 7, the spring 232 is configured to apply a forcebetween 3 N and 15 N, and more particularly between 9 N and 11 N to theplunger 270 and to the slider 234. The plunger 270 can cooperate withthe spring 232, or other biasing mechanism, to vary the biasing force ofthe spring 232. For example, another barb could be provided between thebarb 206 depicted in FIG. 4 and the proximal handle end 198. Where FIG.7 depicts a fully depressed position for the plunger 270, if the distalannular shoulder 272 were retained by the barb between the barb 206depicted in FIG. 4 and the proximal handle end 198 in an intermediatedepressed position, a smaller biasing force would be applied by thespring 232 as compared to the biasing force when the plunger 270 is inthe fully depressed position. Alternatively, where the biasing mechanismis air, for example, the distal annular shoulder 272 could include aseal that contacts the inner side surface 244 of the actuator cavity 200varying the volume of air above the slider 234 thus varying the pressureexerted by the air on the slider 234.

The spring 232 can be configured such that very little, if any, force isapplied by the spring 232 on the slider 234 when the plunger 270 is inthe extended position. The operator then primes the suturing device bydepressing the plunger 270. A head 274 of the plunger 270 can bereceived in the plunger head recess 204 so that an upper surface 276 ofthe plunger 270 is flush with the proximal handle end 198 to provide anindication that the device is ready to be actuated. If desired, however,the manually operated member 230 can be moved from the non-actuatedposition to the actuated position with the plunger 270 in the extendedposition, and then the plunger 270 can be depressed to advance theneedle 20. Actuation via this method will not be as quick as when theplunger 270 is first depressed and then the manually operated member isnext depressed.

FIGS. 9-11 depict an alternative suturing device including an actuator312 that differs from the actuator depicted in FIG. 1, while includingthe same elongate body 14 and needle holder 16. With reference to FIG.10, actuator 312 interacts with the elongate body 14 and is operablebetween a first operating position and a second operating position. Theactuator 312 is configured such that movement of the actuator 312 fromthe first operating position toward the second operating position movesthe needle 20 in the advance direction 36. The actuator 312 includes amanually operated member 330, which differs from the manually operatedmember 230, a biasing mechanism 232, which is a spring and can be thesame as the spring 232 described above, and a slider 234, which is thesame as the slider 234 described above.

The manually operated member 330 is operatively connected with thebiasing mechanism 232 (through the slider 234 in the illustratedembodiment) so as to preclude the biasing mechanism 232 from moving theactuator 12 toward the second operating position until after themanually operated member 330 has been moved from a non-actuated positiontoward an actuated position. The manually operated member 330 differsfrom the manually operated member 230 described above in that themanually operated member 330 is bi-directional. The manually operatedmember 330 includes a first operator contact surface 338, which isconcave in the illustrated embodiment, a second operator contact surface340, which is also concave in the illustrated embodiment and on anopposite side of the manually operated member 330.

With reference back to FIG. 9, the suturing device 310 also includes ahandle 350 that differs from the handle 50 described above. Thedifferences between the handle 350 and the handle 50 will be describedwith the understanding that the other portions of the handles aresimilar. An outer side surface 352 of the handle 350 is convex in theillustrated embodiment, and both operator contact surfaces 338, 340 areconcave to provide an indication of the location of the operator contactsurfaces 338, 340. Both operator contact surfaces 338, 340 extendoutwardly from a widest diameter of the outer side surface 352 of thehandle 350 to also facilitate their location. The manually operatedmember 330 operates as a push button in the illustrated embodimentwhereby an operator, such as a surgeon, depresses the first operatorcontact surface 338 in the direction of arrow 356, or the surgeondepresses the second operator contact surface 340 in the direction ofarrow 358 moving the manually operated member 330 from the non-actuatedposition toward the actuated position. The manually operated member 330includes a slider opening made up of a first outer portion 364 nearer tothe first operator contact surface 338, a second outer portion 366nearer to the second operator contact surface 340 and a smaller centralportion 368 between the first outer portion 364 and the second outerportion 366.

The first outer portion 364 and the second outer portion 366 of theslider opening are each configured to receive the reducedcross-sectional portion 256 of the slider 234 when properly aligned withthe reduced cross-sectional portion 256. This occurs when the operatorpresses the first operator contact surface 338 in the direction of arrow356 thus moving the manually operated member 330 to the right per theorientation shown in FIG. 10, or when the operator presses the secondoperator contact surface 340 in the direction of arrow 358 thus movingthe manually operated member 330 to the left per the orientation shownin FIG. 10. Both the first outer portion 364 and the second outerportion 366 of the slider opening, however, are smaller than therelatively larger cross-sectional portion 258 of the slider 234. Thesmaller central portion 368 of the slider opening is configured to allowfor passage of the wire 40 to allow for the connection of the wire 40 tothe slider 234. When the manually operated member is in the non-actuatedposition, the manually operated member 230 contacts the slider 234 topreclude movement of the slider 234 with respect to the manuallyoperated member 230.

The handle 350 includes a first manually operated member hole 378extending into the handle 350 from the outer side surface 352 of thehandle 350 into an actuator cavity 380, which is similar inconfiguration to the actuator cavity 25 described above. The handle 350also includes a second manually operated member hole 382 extending intothe handle 350 from the outer side surface 352 of the handle 350 into anactuator cavity 380. The suturing device 310 does not include a plungerlike the plunger 270 described above. Accordingly, the handle 350includes a closed proximal end portion 390, which defines a springcontact surface 392 against which the spring acts.

It will be appreciated that various of the above-disclosed and otherfeatures and functions, or alternatives or varieties thereof, may bedesirably combined into many other different systems or applications.Also that various presently unforeseen or unanticipated alternatives,modifications, variations or improvements therein may be subsequentlymade by those skilled in the art which are also intended to beencompassed by the following claims.

The invention claimed is:
 1. A suturing device comprising: an elongatebody including a proximal end portion and a distal end portion; a needleholder extending away from the distal end portion or provided as part ofthe distal end portion of the elongate body, the needle holder includinga distal end section having a distal-most tip, the needle holderdefining a needle passage and a distal opening; a needle received in theneedle passage and having a suture connected thereto; and an actuatorinteracting with the elongate body and operable between a firstoperating position and a second operating position, wherein the actuatoris configured such that movement of the actuator from the firstoperating position toward the second operating position moves the needlein an advance direction, the actuator including a manually operatedmember and a biasing mechanism biasing the actuator toward the secondoperating position, the manually operated member being operativelyconnected with the biasing mechanism so as to preclude the biasingmechanism from moving the actuator toward the second operating positionuntil after the manually operated member has been moved from anon-actuated position toward an actuated position.
 2. The suturingdevice of claim 1, wherein the needle passage is curved.
 3. The suturingdevice of claim 1, wherein the biasing mechanism is a spring.
 4. Thesuturing device of claim 3, wherein the spring is configured to apply aforce between 3 N and 15 N to move the actuator from the first operatingposition toward the second operating position.
 5. The suturing device ofclaim 3, wherein the spring is configured to apply a force between 9 Nand 11 N to move the actuator from the first operating position towardthe second operating position.
 6. The suturing device of claim 3,further comprising a handle connected with the elongate body, whereinthe spring is positioned inside the handle.
 7. The suturing device ofclaim 6, further comprising a plunger connected with the handle andmovable between an extended position and a depressed position, whereinmovement of the plunger from the extended position to the depressedposition compresses the spring.
 8. The suturing device of claim 7,wherein the spring when compressed by the plunger is configured to applya force between 9 N and 11 N to move the actuator from the firstoperating position toward the second operating position.
 9. The suturingdevice of claim 7, wherein the spring when compressed by the plunger isconfigured to apply a force between 3 N and 15 N to move the actuatorfrom the first operating position toward the second operating position.10. The suturing device of claim 1, further comprising a handleconnected with the elongate body, wherein the handle includes an outerside surface, wherein the manually operated member includes a firstoperator contact surface, wherein the outer side surface is convex andthe operator contact surface is concave.
 11. The suturing device ofclaim 10, wherein the outer side surface that follows a surface ofrevolution along at least a portion of the handle, wherein the firstoperator contact surface extends outwardly from a widest diameter of theouter side surface.
 12. A suturing device comprising: an elongate bodyincluding a proximal end portion and a distal end portion; a needleholder extending away from the distal end portion or provided as part ofthe distal end portion of the elongate body, the needle holder includinga distal end section having a distal-most tip, the needle holderdefining a needle passage configured to hold an associated needle and adistal opening; and an actuator interacting with the elongate body andoperable between a first operating position and a second operatingposition, wherein the actuator is configured such that movement of theactuator from the first operating position toward the second operatingposition moves the associated needle in an advance direction, theactuator including a manually operated member and a biasing mechanismbiasing the actuator toward the second operating position, the manuallyoperated member being operatively connected with the biasing mechanismso as to preclude the biasing mechanism from moving the actuator towardthe second operating position until after the manually operated memberhas been moved from a non-actuated position toward an actuated position,wherein the actuator includes a slider and a wire connected with theslider, wherein the biasing mechanism acts against the slider to movethe slider and the wire.
 13. The suturing device of claim 12, whereinthe slider includes a reduced cross-sectional portion extending from arelatively larger cross-sectional portion and the manually operatedmember includes a slider opening configured to receive the reducedcross-sectional portion when the slider opening is aligned with thereduced cross-sectional portion.
 14. The suturing device of claim 13,wherein the slider opening is smaller than the relatively largercross-sectional portion.
 15. The suturing device of claim 14, whereinthe manually operated member includes a first operator contact surface,the manually operated member being configured to be moved in a firstdirection when moving from the non-actuated position toward the actuatedposition.
 16. The suturing device of claim 15, wherein the manuallyoperated member includes a second operator contact surface, the manuallyoperated member being configured to be moved in a second direction whenmoving from the non-actuated position toward the actuated position,wherein the second direction is different than the first direction. 17.The suturing device of claim 16, wherein the first direction is oppositeto the second direction.
 18. The suturing device of claim 13, whereinthe manually operated member is aligned with a relatively larger mainportion of the slider opening when the manually operated member is inthe actuated position, and the manually operated member contacts theslider to preclude movement of the slider with respect to the manuallyoperated member when the manually operated member is in the non-actuatedposition.
 19. A suturing device comprising: an elongate body including aproximal end portion and a distal end portion; a needle holder extendingaway from the distal end portion or provided as part of the distal endportion of the elongate body, the needle holder including a distal endsection having a distal-most tip, the needle holder defining a needlepassage configured to hold an associated needle and a distal opening;and an actuator interacting with the elongate body and operable betweena first operating position and a second operating position, wherein theactuator is configured such that movement of the actuator from the firstoperating position toward the second operating position moves theassociated needle in an advance direction, the actuator including amanually operated member and a biasing mechanism biasing the actuatortoward the second operating position, the manually operated member beingoperatively connected with the biasing mechanism so as to preclude thebiasing mechanism from moving the actuator toward the second operatingposition until after the manually operated member has been moved from anon-actuated position toward an actuated position, wherein the biasingmechanism is configured to apply a force between 9 N and 11 N to movethe actuator from the first operating position toward the secondoperating position.
 20. The suturing device of claim 1, wherein thebiasing mechanism is configured to apply a force between 3 N and 15 N tomove the actuator from the first operating position toward the secondoperating position.
 21. The suturing device of claim 1, wherein themanually operated member includes a first operator contact surface, themanually operated member being configured to be moved in a firstdirection when moving from the non-actuated position toward the actuatedposition.
 22. The suturing device of claim 21, wherein the manuallyoperated member includes a second operator contact surface, the manuallyoperated member being configured to be moved in a second direction whenmoving from the non-actuated position toward the actuated position,wherein the second direction is different than the first direction. 23.The suturing device of claim 22, wherein the first direction is oppositeto the second direction.
 24. The suturing device of claim 22, whereinthe first direction is transverse to a direction in which the biasingmechanism biases the actuator.
 25. The suturing device of claim 24,wherein the first direction is perpendicular to a direction in which thebiasing mechanism biases the actuator.